eCarbon IBDs— 510(k) K191537

Substantially Equivalent

Back 2 Basics Direct, LLC

FDA 510(k) clearance K191537 for eCarbon IBDs, Substantially Equivalent on 2019-09-26. Applicant: Back 2 Basics Direct, LLC.

Clearance details

Applicant: Back 2 Basics Direct, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-06-10
Decision date: 2019-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Independence, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.